One problem this invention intends to address is urinary incontinence, but the invention is applicable to a broader range of problems. The background, however, will discuss urinary incontinence as an example.
Urinary incontinence is an involuntary release of urine when increases in abdominal pressure, caused by sneezing, coughing, or exercising, are not uniformly transmitted to the proximal urethra, resulting in urine xe2x80x9cleakage.xe2x80x9d Moderate stress urinary incontinence (xe2x80x9cSUIxe2x80x9d) is inconvenient and can be a social and hygienic problem, while severe SUI can be disabling. SUI occurs in women and is caused by either hypermobility of the bladder neck and proximal urethra (excessive downward and rotational movement of the bladder neck) or intrinsic sphincter deficiency.
Several defects can result in loss of support of the bladder neck. Examples of these defects are: (a) breakage or abnormal stretching of the passive supports of the bladder and urethra (those connective tissues supporting these structures); or (b) loss of the active support of the bladder neck, vagina, and rectum provided by the levator ani muscle. For instance, one example of passive support failure is paravaginal xe2x80x9cdefectsxe2x80x9d caused by separation of the vaginal wall from the pelvis caused by breakage or stretching of connective tissue (pelvic organ prolapse). Such separation results in downward rotation of the vaginal wall, which in turn results in downward rotation of the bladder neck because the bladder is partially supported by the vagina. An example of loss of active support is loss of muscle tone in the levator ani muscle. This muscle operates as a floor, or platform, supporting the bladder during standing and normal activity. Normal muscle tone of the levator ani relieves the passive support of the pressures caused by overlaid abdominal viscera. Loss of muscle tone may result in downward rotation of the bladder.
Treatment of SUI caused by hypermobility of the bladder and proximal urethra requires supporting the bladder neck, generally at the urethrovesical junction (xe2x80x9cUVJxe2x80x9d). Correction requires support of the UVJ area, which helps balance increased abdominal pressures and which allows the bladder neck to properly compress and close in response to increased pressures, thus preventing urine leakage. Support may be provided in various surgical procedures, including anterior colporrhaphy, retropubic urethropexy, vaginal needle urethropexy, and suburethral sling procedures.
One particular type of surgery is briefly discussed-retropubic urethropexy (xe2x80x9cRUxe2x80x9d). In RU, a series of sutures are used to support the UVJ. The ends of the sutures attach at various points in the body cavity depending upon the type of failure (loss of active support, failure of a portion of passive connective tissue, etc.). The sutures support and properly elevate the bladder neck at the UVJ to maintain the compressibility and pliability of the urethra and to avoid compromising the urethral sphincteric mechanism.
In various RU procedures, different anchoring tissues are used to support the sutures. These anchoring tissues include, but are not limited to, soft tissues such as pubocervical fascia, pubourethral ligaments, Cooper""s ligaments, and rectus fascia. One RU procedure, generally known as the Marshall-Marchetti-Kantz procedure, uses several sutures, with the one end of each suture being attached to the vaginal wall adjacent to the urethra straddling the UVJ bilaterally. The opposite suture end passes through the retropubic periosteum.
In another RU procedure, known as the Burch procedure, the first end of a series of sutures is positioned in both sides of the vagina wall (straddling the urethra) below Cooper""s Ligament 602, and the other end of the sutures is positioned in Cooper""s Ligament 602, thereby supporting the vaginal wall and the UVJ.
RU procedures generally support an area by using sutures, and additional support is provided by using slings (either man-made materials or tissue grafted material) placed under the area to be supported and sutured into an anchoring tissue, such as in suburethral sling procedures (e.g. a Goebell-Stoeckel procedure).
Problems associated with surgical correction of the failed support mechanisms include under- or over-correction of the UVJ. The surgeon must determine the degree of support necessary to properly elevate and support the UVJ to properly address the SUI problem. This determination must be made both pre- and intra-operatively. Too little elevation causes SUI to remain, although the degree of SUI may be reduced. Too much elevation can result in voiding dysfunction (reduced capacity or inability to void), prolonged catheterization, and the need for postoperative correction.
The incidence of postoperative urinary retention can be as high as 30% at two weeks after surgery, and 5% of patients have postoperative urinary retention that persists. Many patients with less severe cases of postoperative obstructive symptoms also benefit greatly. Symptomatic detrusor instability represents the bladder""s response to increased outlet resistance caused by an improperly tensioned sling. The incidence of postoperative irritative symptoms secondary to detrusor instability can be as high as 20%. Appropriate tensioning of the sling minimizes persistent incontinence and voiding dysfinction.
Generally, all of the above procedures require placement of sutures into an anchoring tissue or tissues and may also require placement of sutures into supporting devices, such as slings. Placement is provided through suturing needles, either straight or arcuate, or the use of needle suturing devices, such as push and catch systems, or non-adjustable fascial attachment systems. The suture placement in the tissue can be completely through the tissue or partially through the tissue.
Accordingly, the invention is a tissue anchoring system, including a tissue anchoring device and tissue anchors. At least one embodiment of the tissue anchoring system will be used in soft tissue. The tissue-anchoring device includes housing and a tissue anchor. The tissue anchor is placed on the tissue-anchoring device that is advanced into a tissue. The device may optionally have a plunger assembly slidably positioned in the housing to assist advancing the anchor into a tissue. The tissue anchor has a barb end and a shaft. The barb end is adapted to resist removal from a tissue after it is inserted. The tissue anchor shaft and the barb end may be hollow. The shaft of the anchor has an attachment member distal from the barb end so that the attachment member may attach directly to tissue or attach to tissue using sutures or a sling. The tissue anchors may be adjustable.
It is an object of the invention to provide a tissue-anchoring device that does not require suturing to attach to tissue.
It is an object of the invention to provide a tissue-anchoring device that may be repeatedly reloaded with anchors.
It is an object of the invention to provide a tissue-anchoring device that may insert completely through a tissue or partially through a tissue.
It is an object of the invention to provide an alternative to sutures in relatively inaccessible areas.
It is an object of the invention to provide a tissue-anchoring device that can be hand-held or used with endoscopic surgery techniques and devices, especially flexible endoscopes.
It is an object of the invention to provide an adjustable tissue-anchoring device to adjust the placement of devices or tissues attached to the anchor postoperatively without further invasive surgery.
It is an object of the invention to provide an adjustable tissue-anchor device attachable to tissue using sutures or staples when a surgeon deems it more suitable.